MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE 100W; HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES

Model Number VERSAPULSE POWERSUITE 100W

Device Problems Failure to Deliver Energy (1211); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

A non-lumenis certified service engineer visited the site six (6) days after the reported event.The engineer replaced the blast shield and the foot-switch and then performed safety checks; verifying the system is working within manufacturer specifications and is ready for use.The engineer had also confirmed that facility did not have a spare blast shield and therefor had to cancel the operation.A review of the subject device dhr confirmed that the subject device was installed at the customers site on (b)(6) 2007.A review of historical product complaints from the past two years shows that the same malfunction of foot-switch failure has not led to serious injury.A review of system risk files found the risk of system failure ((b)(4)) which has the potential to lead to ineffective treatment which may require prolonged operation or re-operation.The risk likelihood has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within full risk assessment.A review of subject labeling, (0637-117-01_l - vpps operator manual) revealed in the troubleshooting section what to do in cases of 'no laser power' or 'inadequate or no aiming beam": no laser power: probable cause: the delivery system optical fiber is defective.Suggestion: replace the delivery system.Probable cause: the debris shield is damaged.Suggestion: inspect and, if necessary, replace the debris shield as instructed in the "user maintenance" section of this manual.The debris shield is a user replaceable part that protects the laser system's optical components from damage by a failed delivery system.The debris shield is like a fuse: you only need to replace it if inspection reveals that it is damaged.When a user changes a blast shield it may enable resuming the operation.Although lumenis acknowledges that, there may have been a malfunction with the laser fiber, which caused the blast shield to burn.Based on the information above, due to the lake of a spare blast shield the device operator had to cancel the operation.Although the device malfunction did not cause or contribute to any change in the patient's condition, lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks, thus lumenis is reporting this as an adverse event.According to the gso expert based on the age of the foot-switch, wear could have likely played a role in the failure.Therefore, no additional corrective or preventive action is determined necessary.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).

Event Description

A foreign user facility reported that during a lithotripsy procedure in which a lumenis versapulse 100w laser system was being utilized, the laser lost power and popping sound was heard coming from the area of the fiber.When they released the foot-switch, they noticed the laser continued to fire even after releasing the foot-switch.Emergency switch was used to stop the system.Not having a spare blast-shield the facility had to cancel the procedure.No report of injury was received, and the device malfunction did not cause or contribute to any change in the patient's condition.

• Brand Name: VERSAPULSE POWERSUITE 100W
• Type of Device: HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 10767668
• MDR Text Key: 214814368
• Report Number: 3004135191-2020-00079
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: 07290109140551
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSAPULSE POWERSUITE 100W
• Device Catalogue Number: 0638-803-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1